Risk Management Strategies for Reducing Medication Errors

Reducing Medication Errors
David M. Benjamin, Ph.D.
Clinical Pharmacologist & Forensic Toxicologist,
Consultant in Legal Medicine & Risk Management
Fellow, American Academy of Forensic Sciences (Toxicology)
Fellow, American Society for Healthcare Risk Management
Fellow, American College of Clinical Pharmacology
Fellow, American College of Legal Medicine
Why Do Pts Sue Their Doctors?
Problematic Relationships: 71%*




Communication skills are
as important as clinical
skills in avoiding law
suits!
Deserted PT - 32%
Devalued PT and/or
Family Views - 29%
Delivered Information
Poorly - 26%
Failed to Understand
Patient or Family
Perspective - 13%
*Beckman et al, Arch
Int Med 1994;154:1365
What is a Medication Error?
“any preventable event that may cause or lead
to inappropriate medication use or patient harm
while the medication is in the control of the
healthcare professional, patient, or consumer.
Such events may be related to professional
practice, healthcare products, procedures, and
systems, including prescribing; order
communication; product labeling, packaging,
and nomenclature; compounding; dispensing;
distribution; administration; education;
monitoring; and use.”
www.nccmerp.org
Common Medication Errors








Wrong Drug
Wrong Dose
Wrong Route (of administration)
Wrong Patient
Wrong Time (or omission)
Ambiguous/Illegible Rx->Transcription Error
Inadequate Monitoring (e.g., lack of proper followup)
JC Pt Safety Goal: Must reconcile
medications across a continuum of care
What Information About a Drug
Should you Provide a Patient?*
Nature of the proposed treatment or procedure
 Reasonably Foreseeable material risks
 Appropriate alternative treatments or procedures
 Foreseeable risks if patient becomes pregnant
 Special instructions re: food, drink, lifestyles,
eg, no Chianti with MAOIs
 Tell patients to call if: rash, dark urine, or
anything unexpected occurs;
 Pt should repeat critical info; Ask pt for questions

*Benjamin, DM. Reducing Medication Errors and Increasing Patient
Safety:Case Studies in Clin Pharm, J Clin Pharmacol 2003;43:768-783
Top Five Claims Against Physicians
(Mass Pro-Mutual Ins Co., 2003)
(They’re still the same!)
Failure to Diagnose
 Misinterpretation of Laboratory Test or Study
 Failure to Conduct a Proper History & Physical
 Failure/Delay in Obtaining a Timely Referral or
Consult
 Failure/Delay in Admitting a Patient to the
Hospital

Quality Improvement: A Refocus on
Errors - What Got Everything Started?
The Institute of Medicine issued:
To Err is Human which reported that
44,000 - 98,000 patients died each year as a
result of “Medical Error” (e.g., medication
errors, surgical errors, missed diagnoses)
 At an estimated cost to the US
economy of $17-$29 billion

Major Findings of the IOM Study
Based on two reports from three states:
New York (1984), Utah and Colorado (1992)
 NY study sampled 30,000 charts from 51
state hospitals and found:
 3.7% of pts suffered injury severe enough to
disable them or prolong hospitalization
 58% of these injuries were due to error;
13.6% were fatal

Major Findings of the IOM Study-2
The 98,000 number was extrapolated from
the NY study, based on the number of
hospitalizations for 1997
 Based on reports from Utah and Colorado
(1992), 15,000 charts were sampled
 44,000 deaths was extrapolated from these
data
 The IOM report has been criticized by one of
the investigators, Troyen Brennan, MD, JD,
MPH of the Harvard School of Public Health

Develop a Philosophy
of Patient Safety
Recognize the patient’s needs
 Be alert for better ways to do things
 Record & track medication/medical error and
investigate all instances & “near misses”
 Re-engineer faulty medication delivery
systems to reduce the risk of errors (RCAs)
 Focus on the system, not the person

Patient Safety and
Quality Improvement Act of 2005
(S. 544 - Public Law N 109-41- Passed July 29, 2005)





Report errors anonymously to Patient
Safety Organizations (PSOs)
Obtain legal privilege for reports
Analyze non-identifiable pt. safety data
Develop national standards promoting
interoperability and health care
information technology systems
Develop Med Info Technology Advisory
Board to determine: best practices in IT,
lexicon for computer technology; RFID,
Bar Coding using NDC number.
Risk Management Strategies
For Preventing Law Suits




Be Professional and Courteous
Keep Good Records and Never alter a patient’s
chart in the event of, or fear of litigation - your
credibility becomes 0
Provide an Adequate Informed Consent &
Instructions to call at the first sign or symptom of a
serious ADR
Project Realistic Outcomes & Expectations, e.g.,
don’t say “It won’t hurt”, say “We will manage
the pain and keep you comfortable.”
Elements of a Negligence Claim
Physician-Patient relationship established,
or professional owed a duty of reasonable
care to patient
 Physician’s conduct was below the standard
of care (what a reasonable MD would have done

under similar circumstances)
Patient was injured (damages)
 Negligence was a “Proximate Cause” of the
patient’s damages

Types of Adverse Drug Reactions
(ADRs) Frequently Encountered
Overmedication - too much or too many
 Side Effect - an undesirable drug effect
 Secondary Effect - additional drug effects
 Allergic Reactions - e.g., to antibiotics
 Idiosyncratic - rare
 Maternal-Fetal - in utero or during nursing
 Drug-Drug Interactions - ADME
 Alternative Medical Products &
OTC drugs

Take a Complete Drug History
Including Alternative Medical
Products
“Natural Products”, e.g., St. John’s Wort
is an MAOI & Reduces serum Digoxin levels
 Kava Kava causes liver damage
 Herbals, e.g., Ephedrine-containing
 Food Supplements, e.g., L-Tryptophan
 Androgenic Supplements - Heart Failure
 Vitamins & Minerals in Excessive Doses,
e.g., >10,000 IU Vitamin A/day--> Toxicity
 OTC Drugs

Identifying High Risk Drugs
Low Therapeutic Index: digoxin, anti-coagulants
 Inherent Undesirable Effect(s), e.g., steroids, chemo
 Class of Drugs Which Share Toxicity: NSAIDs, ACEIs
 Drug Allergies - antibiotics; cross-sensitivity
 Narcotics - Patient Controlled Analgesia
 Newly Approved Drugs - Minimal Safety Data
 “Off-Label” Use of Drugs, e.g., Fen-Phen
 Pharmacokinetic Drug Interactions, e.g., SSRIs
 Advertised: Direct-to-Consumer, “Doctor,
can I have some of that stuff I saw on TV?”

What Classes of Drugs are Involved
in Common Medication Errors?
Antibiotics: 19-30%
 Analgesics: 7-30%
 Cardiovascular: 8-18%
 Concentrated electrolytes: 1-10%
 Antineoplastic drugs: 7-8%
 Sedatives: 4-8%
 Anticoagulants: 1.3-3% (1000U Heparin)
Source: Agency for Healthcare Research and
Quality (AHRQ) sponsored studies

Classes of Drugs Appearing
Twice During 1996-98 in
PHICO’s Closed Claims Project*





Antibiotics
Anticoagulants
Antirheumatics
Tranquilizers
Concentrated
electrolytes





Insulin
Oral Antidiabetics
Antihypertensives
Opiates
Fibrinolytics
*Benjamin, DM and Pendrak, RF. : Medication Errors: An
Analysis Comparing PHICO’s Closed Claims Data and
PHICO’s Event Reporting Trending System (PERTS).
Clin Pharmacol 2003;43:754-759.
J
Medication Errors Appearing
in PHICO’s 1998 Closed Claims*




Allergic/Adverse
Reaction (25%)
Contraindicated drug
administered (22%)
IM Technique Issue
(10%)
Incorrect dose (10%)




Wrong Patient (3%)
Wrong route (3%)
Labeling/dispensing
error (1%)
Not classified: eg,
failure to monitor or
prescribe
*Benjamin, DM and Pendrak, RF. : Medication Errors: An
Analysis Comparing PHICO’s Closed Claims Data and PHICO’s
Event Reporting Trending System (PERTS).
J Clin
Pharmacol 2003;43:754-759.
What to do About “High Risk” Drugs
Recognize and Identify them!
 Limit use to when needed; employ prewritten “Limit Dose” Protocols
 Review and update protocols for
administration to insure proper dosing, lack
of drug-drug interactions, & adequate
monitoring
 Use appropriate laboratory tests (e.g., ProTimes) or blood level monitoring to confirm
proper therapeutic response and safety

Proximal Causes of Medication Errors:
Leape, LL et al, System Analysis of Adverse Drug Events, JAMA, 1995;274:35-43.
Lack of Knowledge About the Drug
 Lack of Information About the Patient
 Rule Violations
 Slips and Memory Lapses
 Transcription Errors
 Faulty Drug Identification
 Dosing Errors
 Infusion Pump/Parenteral Delivery Error
 Inadequate Monitoring
 Preparation Errors

Lack of Knowledge
About the Drug





Inadequate knowledge of :
Indications
Dosage
Routes of Administration
Chemical Incompatibilities or
Drug Interactions
Lack of Information
About the Patient





Allergies or
Sensitivities
Current Diagnosis
Secondary Diagnoses
Concomitant
Medications
Prior Medical History
Case Study
A 63 yo white male has been receiving enalapril for one year for
the treatment of his hypertension. Last week, he experienced
some difficulty swallowing and discomfort in the back of his
throat. He called his doctor and was told to go to the emergency
room at the local hospital. Upon arrival in the ER, the patient
was experiencing some mild breathing difficulty and was treated
with Benadryl, 50 mg, IM and oxygen by mask. Within 30
minutes, the patient was breathing more comfortably and was
admitted to a general medical floor for observation.
The next morning, the patient’s wife arrived with a bag of the
patient’s “other medications”, which she said she administered
to her husband every day. The nurse called the admitting
physician and received permission to administer the patient’s
other meds, during the course of which, she also administered
another dose of enalapril.
The patient was discharged later that day. The day following
discharge, the patient suffered an episode of acute
angioneurotic edema with dysphagia, lip swelling, airway
obstruction, and expired before paramedics could respond.
Conduct a Root Cause Analysis and determine:
What “System Errors” (shown on next slide) Occurred?
What can be done to prevent a recurrence?
Proximal Causes of Medication Errors:
Leape, LL et al, System Analysis of Adverse Drug Events, JAMA, 1995;274:35-43.
Lack of Knowledge About the Drug
 Lack of Information About the Patient
 Rule Violations
 Slips and Memory Lapses
 Transcription Errors
 Faulty Drug Identification
 Dosing Errors
 Infusion Pump/Parenteral Delivery Error
 Inadequate Monitoring
 Preparation Errors

Enalapril Case Process (Basic
Minimum)
Patient Admitted
Rx from Home
Nurse obtained “Telephone okay” from MD to
administer med brought from home
Rx from home given to patient with
catastrophic result
Discharge plan; No Medication Reconciliation
(Do not give ACEIs to Pt)
Correct Process
Patient
Admitted
Entered into Record
Rx from
Home
Reviewed by Pharmacy
Approved by
Pharmacy per Care
Plan
Questioned by
Pharmacy
Rx on EMAR For
Hospital Use
Confer with MD
Discharge Plan
Medication
Reconciliation
Approved Rx per MD
Hold back Specific Rx
per MD
The Data (Evidence)-Based
Route Cause Analysis (RCA)
E=Event
M=Mode,
unexplained
fact
H=Hypothesis
Courtesy of Reliability Center,
Inc. 2012
Medication Use Process
T r a n s c r i p t i o n
Prescribing -> Dispensing -> Administering -> Monitoring
C o m m u n i c a t i o n
How do the Most Common Types
of Medication Errors Arise?
Physician ordering: 39-49%
 Nursing administration: 26-38%
 Transcription error: 11-12%
 Pharmacy dispensing error: 11-14%
Source: Bates et al JAMA 1995;274(1):29-34
& Leape et al JAMA 1995;274(1):35-43.

Slips and Memory Lapses








Mental Lapses
Intellectual Errors
Stress
Attention Diverted by:
Page
Someone Talking to You
Phone Call
You’re Only Human
Why Use CPOE?



MD computerized order
entry decreased serious
medication errors 55% and
Potential undetected
Adverse Drug Experiences
(ADE) declined 84%
Bates et al JAMA
1998;280:1311-1316
Still Problems With CPOE






CPOE Software Differ
In 2003, the USP found that 57.9% of CPOE
involved Lack of Knowledge
Computer Entry ranked as the 4th leading cause of
errors in 2003
67% of errors occurred during the prescribing phase
56.5% of all computer entry errors resulted from
distraction
JC Pt Safety Goal: Must reconcile
medications across a continuum of care
Errors in Prescription Writing
Legibility - Poor Handwriting is Not a Joke !
Lamisil vs. Lamictal
 Dosage: Start Low - Go Slow !
 How many pills? How many refills?
For how long?
 Use of Unapproved Abbreviations, eg “U”,
QOD, QD (JC Pt. Safety Goals)
 Brand vs. generic name mix-ups
enalapril (Vasotec) vs. Elderpryl (selegiline)

Portrait of a Poor Prescription
Source: AMA Website
The Correct Drug was . . .

Final Answer: Isordil
not Plendil which was
dispensed and caused
fatal hypotension for
which both the MD
and RPh were held
jointly liable for
almost $500,000.
Transcription Errors
“Look-Alike” and “Sound Alike” Names



Confusion Over: Drug
Names or Handwriting
Larocin 250 mg vs.
Lanoxin 0.250 mg
(Larocin changed to
Larotid after mix-up)
Losec changed to
Prilosec after confusion
with Lasix
Heparin 1000U sc q 4 hrs
Can’t abbreviate Units,
you risk a ten-fold OD!
More Sound-alike, Look-alike Drugs












Amicar
Cardura
Darvocet
Effexor
hydrocodone
MS Contin
Tramadol
Zestril
Zocor
Oxycontin
hydroxyzine
lorazepam












Omacar
Coumadin
Percocet
Effexor XR
oxycodone
Oxycontin
trazodone
Zyprexa
Zyrtec
oxycodone
hydralazine
alprazolam
Avoiding Prescription Errors




Write Legibly

Don’t Guess
Be Careful with “look

alike” names, e.g.,
Elderpryl vs enalapril
Consider writing in the

indication to further
avoid confusion, e.g.,
Elderpryl for
Parkinson’s Disease
Avoid ten-fold dosing
errors: write 1 mg instead
of 1.0 mg.
Conversely, write: 0.250
mg Lanoxin, not .250 mg,
where decimal can be lost
Write 4 times per day not
4 x daily; Is this qid or
for 4 consecutive days?
Avoiding Ambiguity in
Prescription Writing
Consider writing the condition for which
the medication is indicated on the
prescription, under the drug name.
 Examples:
 Lamictal 100 mg bid for seizures
 Lamisil 250 mg daily for fungal infection

Avoiding Ambiguity in
Prescription Writing
Consider writing both the Brand name and
the generic name of the medication
 Examples:
 Vasotec (enalapril) 2.5 mg daily for
hypertension
 Elderpryl (selegiline) 5 mg bid for
Parkinson’s Disease

Hint: When it Comes to ZeroesAlways Lead and Never Follow!
Always write: 1 mg not 1.0 mg
eg, Lanoxin 0.125 mg vs Xanax 1.0 mg hs
Correct
Incorrect*
*Should be written: Xanax 1 mg hs
Patient Factors Influencing the
Drug Selection Process
1. Renal Disease
2. Hepatic Disease
3. Level of CYP Isoenzymes [clinically available]
4. Interaction with other drugs being taken
5. Allergic response in past
6. Prior experience resulting in an ADE
Richard S. Blum 2004
Criteria to be Considered
Number of Drugs being taken
 Long Acting & Administration Ability
 CYP interference
 Creatinine Clearance
 T/E Code rating (Therapeutic Index, TI)
 No Patient should be financially penalized
because of a medical/pharmacologic
problem.

Richard S. Blum 2005
The “First Year” Effect



Patients exposed to new
drug increases from
thousands to hundreds of
thousands or millions,
New adverse reactions
emerge, or
Previous incidence takes
on new perspective.
For example: The Short Life of
Omniflox (temofloxacin)





Introduced: Jan 1992
First Rx: February 24
Voluntarily withdrawn:
June 9th - 15 weeks
US Clin Trials 4,600 pts
Mkt’d in 8 countries
Est. 300,000 pts rec’d
drug worldwide
Pre- vs Post- Marketing
Adverse Drug Reaction Reports





Pre-Marketing
4,261 pts
Incidence > 1%
N,V,D, headache,
rash, itching
Labs: Incr. BUN &
creatinine
Renal Failure <0.1%





Post-Marketing
fewer than 300,000 pts
1,700 non-fatal ADRs
reported to FDA
54 cases of Acute
Renal Failure, 113
cases of hemolytic
anemia
60 deaths, 25-50 may
be related; Globe 1/94
Other Post-1960s Fiascoes
We Have Known and Loved








1970s
DES
IUDs
DPT/MMR
1980s
Oraflex, Zomax,
Suprofen
Generic Drugs
Bendectin








1990s
L-Tryptophan - EMS
Omniflox - 5-month life
Toradol - 5-day labeling
Imitrex - First-Year Effect
Silicone Breast Implants
Fen-Phen - “Off-Label” use
Duract - Where is Dr. Kelsey
when we still need her?
More Withdrawn Drugs
Posicor® - too many interactions
 Rezulin® - liver toxicity
 Raxar® - cardiac arrhythmias
 Propulsid® - too many interactions
 Seldane/Hismanyl® - long QT syndrome
 Rotashield® - infant bowel obstruction
 Lotronex® - off Nov 2000 GI ADRs &
deaths; Re-instituted 2002 w/pt FU
 Baycol® (are other “statins” to follow?)
 Vioxx® & Bextra®– MIs & CVAs

Drug Interactions
Pharmacokinetic
 Pharmacodynamic

Pharmacokinetic
Absorption
 Distribution
 Metabolism
 Excretion

Metabolism
Carried out in liver by CYP-450 enzymes, of
which there are 5 families:
 CYP3A4 (54%) (eg, methadone)
 CYP2D6 (25%) (eg, codeine, methadone,
hydrocodone, oxycodone)
 CYP2C (17%)
 CYP 1A2 (2%) (eg, methadone)
 CYP2E1 (2%) (eg, ETOH & acetaminophen)

The USP’s MedMARx System
The United States Pharmacopeia (USP) has
established a nationwide program for
reporting Medication Errors
 Notice the emphasis is now on Medication
Errors rather than Adverse Drug Reactions
 Errors are categorized according to severity
and outcome (see next slide).
 Hospitals pay a fee to join the program and
receive software; Anyone can report to
MERP

USP MedMARx Reporting Program
Severity Levels and Outcomes
Category A - Circumstances can cause error
 B: Error occurred - didn’t reach pt -“near miss”
 C: Error occurred - reached pt-> no harm
 D: Error occurred - no harm->monitoring
 E: Error occurred - tx required -> temp harm
 F: Error occurred->initial or prolonged hosp
 G: Error occurred-> permanent pt harm
 H: Error occurred-> near-death event
 I: Error occurred -> resulted in pt death

Benefits of Reducing
Medication Errors in the ICU






92% of errors involved MD
ordering
Preventable ADEs decreased 66%
12% of time cheaper or safer drugs
were recommended by PharmD.
Each preventable ADE costs
approximately $4,685
Estimated savings/year: $270,000
Leape et al JAMA 1999;282:267-70
Benefits of Reducing Medication
Errors








Optimize Therapeutics
Improve Care
Increase Pt Satisfaction
Decrease ADRs
Reduce Risk of
Litigation
$ave Money
30 Day Rule
Do it Right!
The 30-Day Rule
Minimizing Readmissions
Preventing Medication Errors:
Make the Proper Diagnosis & Give
the Correct Drug to the Right Patient
Risk Management
Quality Improvement
Quality Assurance
Utilization Review
Evidence-Based
Medicine
Drug Selection
Outcomes
Research
Cost Control
Contracted Formularies
Drug-1 vs Drug-2
Contracted Formularies
Evidence-Based Drug Selection
Choices
Drugs with
similar chemical structure
Barbiturate
hypnotic
Secobarbital
Pentobarbital
Drugs with
similar mechanism of action
Drugs with
similar pharmacologic effects
Benzodiazepine
hypnotic
Antihistamine
Dalmane®
(flurazepam)
Halcion®
(triazolam)
Ambien
(zolpidem)
Benadryl®
diphenhydramine